Cleared Traditional

PERIODONTAL DEBRIDING SOLUTION E (K903163) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903163 · Dentsply Intl. · Dental device
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Oct 1990
Decision
84d
Days
Class 2
Risk

K903163 is an FDA 510(k) clearance for the PERIODONTAL DEBRIDING SOLUTION E. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on October 10, 1990 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dentsply Intl. devices

Submission Details

510(k) Number K903163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1990
Decision Date October 10, 1990
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

All 35
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K903163.
JET UNIT (CJ HANDPIECE)
K941392 · Dentsply Intl. · May 1994
THE MODEL 3003 SCALER
K930698 · Dentsply Intl. · Jul 1993
DIAMOND COATED DENTAL INSERTS
K923639 · Dentsply Intl. · Oct 1992
SONIC SCALER
K902413 · Dentsply Intl. · Aug 1990
PERIODONTAL IRRIGATING SOLUTION-D
K894247 · Dentsply Intl. · Oct 1989
ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30
K864996 · Dentsply Intl. · Feb 1987